Lafiyan Jikin Mata "Excellent Health for Mothers"

NCT02214875 | Completed DMC

• 1 other identifier: C6-TSA-037
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to address the research question: Will continuous quality improvement, using a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of HIV-infected pregnant women and mothers at six and 12 months postpartum? Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to systematically improve services and health outcomes. The Break Through Series (BTS) is a specific CQI approach is a short-term (6- to 15-month) learning system that brings together teams from several hospitals or clinics ("collaboratives") to seek improvement in a focused topic area through a common process of data sharing and review Primary Objective To assess whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at health facilities implementing CQI-BTS approaches than at health facilities not implementing CQI-BTS approaches. Secondary Objectives To assess whether implementation of CQI-BTS initiatives at health facilities increases:

1. 1.Uptake of PMTCT services by HIV-infected pregnant women;
2. 2.Retention-in-care of HIV-infected women at twelve (12) months postpartum;
3. 3.Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;
4. 4.Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected women in health facilities.

Conditions

Retention

Keywords

Retention

Outcome Measures

Primary Outcomes (1)

• Proportion of HIV+ pregnant women in care 6 months postpartum

  Denominator= Total number of HIV + pregnant women enrolled to participate in the study Numerator= Total number of HIV + pregnant women retained at six months postpartum

  Six months post partum

Secondary Outcomes (1)

• Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples taken at 6-8 months of life

  2 months post delivery of exposed infant

Study Arms (2)

CQI/BTS

EXPERIMENTAL

Experimental: CQI/BTS CQI/BTS interventions will be applied through rapid structured cycles of data collection, testing of solutions and review of changes will be done. At each site, Quality Improvement Teams (QIT) will be established among facility staff. Local Government/State QI teams will provide oversight function of facility based QI initiatives. Break Through Collaborative Series (BTS) will hold quarterly in each study state at a central location with participants from intervention sites. Sessions will provide opportunity for teams to learn from each other; adapt and implement changes using the Plan-Do-Study-Act (PDSA) model. Process indicators will be used to measure quality improvement from the intervention sites and collaboratives.

Other: CQI/BTS

Control

OTHER

Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.

Other: Control

Interventions

CQI/BTS OTHER

Application of CQI/BTS interventions through employing rapid structured cycles of data collection, testing of solutions and review of changes will be implemented. At each site a Quality Improvement Team (QIT) will be established from among the facility staff. Local Government and State level QI teams will provide oversight function of the health facilities' QI initiatives. BTS as a collaborative learning approach will be conducted quarterly in each study state at a central location with participants from the intervention sites. The sessions will provide opportunity for teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act (PDSA) model.

CQI/BTS

Control OTHER

Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• They must be pregnant women newly diagnosed for HIV during ANC
• Clients must present with gestational age of 34weeks or less at ANC enrollment
• They must accept in principle to take ARVs and remain in care.
• They must be willing to participate until at least six months postpartum
• Must be domiciled in the facility coverage area.
• Previously diagnosed HIV positive pregnant women yet to start ART

You may not qualify if:

• Clients requesting fee/remuneration for participation
• Positive women already on ART.
• Unbooked HIV positive pregnant woman coming in labour.
• Positive pregnant women with gestational age more than 34 weeks.

Sponsors & Collaborators

• Centre for Integrated Health Programs, Nigeria: lead
• Federal Ministry of Health, Nigeria: collaborator
• World Health Organization: collaborator
• Foreign Affairs, Trade and Development, Canada: collaborator

Study Sites (1)

Center for Integrated Health Program

Abuja, Federal Capital Territory, 900288, Nigeria

Location

Related Publications (1)

• Osibo B, Oronsaye F, Alo OD, Phillips A, Becquet R, Shaffer N, Ogirima F, Imarhiagbe C, Ameh B, Ezebuka O, Sodzi-Tettey S, Obi A, Afolabi OT, Inedu A, Anyaike C, Oyeledun B. Using Small Tests of Change to Improve PMTCT Services in Northern Nigeria: Experiences From Implementation of a Continuous Quality Improvement and Breakthrough Series Program. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S165-S172. doi: 10.1097/QAI.0000000000001369.

  PMID: 28498186 DERIVED

Study Officials

• Bolanle Oyeledun, MASTERS

  Center for Integrated Health Program(CIHP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: August 12, 2014
• Study Start: July 14, 2014
• Primary Completion: October 31, 2016
• Study Completion: June 30, 2017
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

NG (1)